CLINIMIX E 2.75/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
Clinical safety rating
cautionComprehensive clinical and safety monograph for CLINIMIX E 2.75/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER (CLINIMIX E 2.75/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER).
Clinimix E 2.75/25 provides amino acids for protein synthesis and dextrose for caloric support in parenteral nutrition. Amino acids serve as substrates for protein synthesis, while dextrose provides a source of glucose for energy metabolism, preventing catabolism and promoting anabolism.
| Metabolism | Amino acids are metabolized via transamination and deamination in the liver; dextrose undergoes glycolysis and enters the citric acid cycle. Electrolytes are excreted or reabsorbed renally. |
| Excretion | Amino acids: renal elimination of metabolites and urea. Dextrose: metabolized to CO2 and water, exhaled via lungs. Electrolytes: primarily renal (90-95%), minor fecal (<5%). No significant biliary excretion. |
| Half-life | Amino acids: not applicable (endogenous turnover). Dextrose: ~1-2 hours (exogenous glucose). Electrolytes: dependent on renal function; not traditionally defined. |
| Protein binding | Amino acids: negligible (<5% bound). Dextrose: negligible. Electrolytes: variable; calcium ~40% bound to albumin, magnesium ~30% bound to albumin, potassium and sodium minimally bound (<5%). |
| Volume of Distribution | Amino acids: total body water (~0.5-0.7 L/kg). Dextrose: total body water (~0.2 L/kg initially). Electrolytes: sodium ~0.6 L/kg, potassium ~0.4 L/kg, calcium ~0.2 L/kg, magnesium ~0.3 L/kg. |
| Bioavailability | Not applicable; administered as intravenous infusion only (bioavailability 100% by IV route). No oral bioavailability. |
| Onset of Action | Intravenous: immediate (within minutes) for metabolic effects (amino acid incorporation, glucose utilization). |
| Duration of Action | Intravenous: variable; amino acids metabolized continuously, glucose cleared within hours; electrolytes maintained via infusion rate. |
| Molecular Weight | Dextrose: 180.16 Da; amino acids vary (e.g., leucine 131.17 Da); calcium: 40.08 Da. As a mixture, no single molecular weight. |
Intravenous administration: Adult dose based on protein and electrolyte requirements; typical infusion rate not to exceed 4 mg/kg/min of dextrose. Daily dose should not exceed 2.5 g/kg amino acids or 25 g/kg dextrose.
| Dosage form | INJECTABLE |
| Renal impairment | In GFR 30-59 mL/min: reduce amino acid dose by 50% and monitor electrolytes closely. If GFR <30 mL/min: avoid or use only with extreme caution, typically restrict protein to 0.6-0.8 g/kg/day and adjust electrolytes per serum levels. |
| Liver impairment | Child-Pugh Class A: no adjustment necessary. Child-Pugh B: reduce amino acid dose to 0.8-1.2 g/kg/day. Child-Pugh C: avoid due to risk of encephalopathy; if essential, restrict to 0.5-0.7 g/kg/day with branched-chain amino acid enrichment. |
| Pediatric use | Neonates and infants: 2-3 g/kg/day amino acids and 10-15 g/kg/day dextrose, titrating gradually. Children: 1-2 g/kg/day amino acids and 5-10 g/kg/day dextrose; rate not to exceed 0.2-0.4 g/kg/h dextrose. Adjust electrolytes per daily requirements. |
| Geriatric use | Elderly patients: start at lower end of dose range; monitor renal function and serum electrolytes closely. Typical amino acid dose 1.0-1.2 g/kg/day, dextrose dose adjusted to avoid hyperglycemia; infusion rate not to exceed 2 mg/kg/min. |
| 1st trimester | Use only if clearly needed; dextrose and amino acids are essential nutrients but high doses may cause metabolic disturbances. Calcium addition may affect fetal bone development. |
| 2nd trimester | Use if benefit outweighs risk; monitor maternal glucose and calcium levels to avoid fetal hyperglycemia or hypercalcemia. |
| 3rd trimester | Use with caution; risk of fetal hyperinsulinism and hypocalcemia. Avoid in eclampsia. |
Clinical note
Comprehensive clinical and safety monograph for CLINIMIX E 2.75/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER (CLINIMIX E 2.75/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER).
| Placental transfer | Dextrose crosses placenta by facilitated diffusion; amino acids are actively transported; calcium crosses by active transport. All components are transferred to the fetus. |
| Breastfeeding | Excretion in breast milk not well studied; dextrose and amino acids are normal milk components. Calcium may be excreted. Use with caution in lactating women, monitor infant for metabolic effects. |
| Lactation Rating | L3 (Moderately Safe) |
| Teratogenic Risk | CLINIMIX E 2.75/25 (amino acids, dextrose, electrolytes, calcium) is a parenteral nutrition solution. No adequate and well-controlled studies in pregnant women. Animal reproduction studies have not been conducted. However, amino acids and dextrose are endogenous substances; electrolyte imbalances can cause fetal harm. In first trimester: avoid unless maternal benefit outweighs risk; deficiencies in essential nutrients may be teratogenic. Second/third trimester: use only if clearly needed; monitor for hyperglycemia (risk of fetal macrosomia, neonatal hypoglycemia). |
| Fetal Monitoring | Monitor maternal serum electrolytes, blood glucose, liver function, renal function, acid-base status, and fluid balance. Fetal monitoring: growth ultrasound to detect macrosomia if maternal hyperglycemia occurs; consider fetal echocardiography if electrolyte abnormalities are severe. |
| Fertility Effects | No data on fertility effects. Nutritional status affects fertility; correcting malnutrition may improve fertility. No known direct adverse effects on reproductive function. |
■ FDA Black Box Warning
Not for use in patients with severe electrolyte imbalances, severe liver disease, or severe renal impairment. May cause hyperglycemia, electrolyte abnormalities, or volume overload. Must be used under medical supervision.
| Serious Effects |
Hyperglycemia not controlled by insulinSevere hypercalcemiaSevere amino acid metabolism disorders (e.g., maple syrup urine disease)Hypersensitivity to any componentSignificant electrolyte imbalance uncorrected
| Precautions | Monitor serum glucose, electrolytes, fluid status, and renal function, Risk of hyperglycemia in diabetic patients, Risk of electrolyte disturbances including hyperkalemia, hypercalcemia, and hyperphosphatemia, Avoid in patients with galactosemia or fructose intolerance, Use caution in hepatic or renal impairment |
| Food/Dietary | No direct food interactions as this is an intravenous product. However, oral intake may be restricted or monitored due to underlying medical conditions (e.g., diabetes, renal failure). Ensure consistent carbohydrate intake if transitioning to oral feeding. |
| Clinical Pearls | CLINIMIX E 2.75/25 is a dual-chamber bag containing amino acids and dextrose with electrolytes, including calcium. Do not use if seals are broken or if solution is discolored. Must be administered via central line due to high dextrose concentration (25%). Avoid simultaneous administration with ceftriaxone due to calcium-ceftriaxone precipitation risk. Monitor serum electrolytes, blood glucose, and liver function tests closely. Not for use in patients with severe hepatic or renal impairment. |
| Patient Advice | This medication provides nutrition through a vein and must be given by a healthcare professional. · Report any signs of infection at the IV site (redness, swelling, pain) or allergic reactions (rash, itching, difficulty breathing). · Inform your healthcare provider if you have a history of diabetes, kidney disease, or liver problems. · This solution contains added calcium; avoid taking additional calcium supplements without doctor approval. · You may experience changes in blood sugar; symptoms of high or low blood sugar (e.g., excessive thirst, urination, shakiness) should be reported. |
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